NCT05374863

Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

Evaluation and Intervention of Intradialytic Physical Therapy in Patients With Chronic Kidney Disease: a Randomized Clinical Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Marcela Cangussu Barbalho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective is to evaluate in adult patients with chronic kidney disease the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength. The hypothesis is that in people with chronic kidney disease on hemodialysis, the addition of neuromuscular electrical stimulation in the upper limbs associated with aerobic training of the lower limbs is superior to aerobic exercise alone in improving functional capacity, peripheral muscle strength, quality of life, safety intervention and patient adherence.

Detailed description

Objective: To evaluate, in adult patients with chronic kidney disease, the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength. Methods. This is a controlled, randomized, double-blind, intention-to-treat clinical trial carried out at the Cassiano Antônio Moraes University Hospital (HUCAM). Thirty individuals who will be randomly allocated to an intervention group (ie active NMES on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes) or a control group (ie NMES-Sham on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes). The treatment will be carried out for 8 weeks, with 3 weekly sessions totaling 24 sessions. Outcome measures will be collected by trained researchers before treatment (week 0) and at the end of treatment (week 9), always in the second hemodialysis session of the week. Functional capacity, peripheral muscle strength, activity level of daily living, quality of life, intervention safety, patient compliance, hemodialysis filtration rate (KT/V) and renal function (potassium, phosphate and magnesium clearance) will be evaluated. Impact. This study could potentially provide important information and assist in clinical decision making regarding the combined use of NMES with a cycle ergometer to optimize the clinical benefits of therapeutic exercise in patients with chronic kidney disease.

Conditions

• Chronic Renal Diseases

Interventions

Type	Name	Description
DEVICE	Neuromuscular electrical stimulation (NMES) - Active	The NMES will be held for 20 minutes. Biceps musculature and bilateral wrist and finger flexors stimulated. For patients undergoing hemodialysis for fistula in the upper limb, NMES will be performed only in the limb without a fistula. points of points 4 electrodes in each, being 2 points of longitudinal position in the muscular belly of the biceps, and other 2 in the ventral region of the forearm. the parameters: frequency of 80 Hz, pulse frequency of 350 ms, time of 5 seconds and 10 seconds. The possibility will be greater for each patient who will have the contraction. Patients will be instructed to perform an isometric contraction of wrist and finger flexors during electrical stimulation.
DEVICE	Neuromuscular Electrical Stimulation (NMES) - Sham	It will be performed in the same way as in the experimental group, however, the intensity of the actuality will only reach the sensitive threshold.
DEVICE	Aerobic exercise with cycle ergometer	The exercise will be performed from the adaptation and positioning of a cycle ergometer (Mini Bike E5 Acte Sports®) in front of the hemodialysis chair. Each session will consist of three phases: duration (5 minutes), conditioning (20 minutes) and cool-down (5 minutes). During the development and cool-down phases, patients will be instructed to maintain a lower exercise intensity, with a level between 1 and 3 on the modified BORG scale. In the conditioning phase, patients will be instructed to slightly increase the intensity of the exercise, levels between 4 and 7 on the modified BORG scale. During exercise, patients will be asked every 5 minutes about the level of effort, and the load on the cycle ergometer will be possible to reach an intensity between 4 and 7 on the modified Borg Scale.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-05-16
• Last updated: 2023-02-21

Locations

1 site across 1 country: Brazil